PCORnet Announces Enrollment of First Participant in ADAPTABLE Aspirin Study

Washington, D.C. – PCORnet, the National Patient-Centered Clinical Research Network today announced enrollment of the first patient in its ADAPTABLE (Aspirin Dosing: APatient-centric Trial Assessing Benefits and Long-Term Effectiveness) study, a three-year pragmatic clinical trial that will compare the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. Pragmatic trials are designed to reflect “real-world” medical care by recruiting broad populations of patients, embedding the trial into the usual healthcare setting, and leveraging data from health systems to produce results that can be readily used to improve patient care.

“PCORnet is shifting the research paradigm through studies like ADAPTABLE by introducing a new genre of patient-centered research where patients are engaged to improve the science of clinical trial design,” said Adrian F. Hernandez, MD, MHS, director of outcomes and health services research at the Duke Clinical Research Institute (DCRI) and PCORnet’s Coordinating Center Co-Principal Investigator.

Using electronic health records (EHRs) and web-based technology, participants will self-consent, self-randomize and report data directly through an online portal. In addition, with participants’ consent, electronic health information captured during routine care will be used to identify events that will provide ADAPTABLE researchers with additional health outcomes data to inform better decision-making. Watch Dr. Hernandez’s video explaining how PCORnet and ADAPTABLE are re-thinking how clinical trials are conducted.

ADAPTABLE is funded through a research award totaling up to $18 million from the Patient-Centered Outcomes Research Institute (PCORI). DCRI is the Coordinating Center for this first demonstration study of PCORnet, an innovative initiative of PCORI involving 33 individual networks working together to make it faster, easier, and less costly to conduct clinical research by harnessing the power of large amounts of health data and patient partnerships. The study plans to enroll 20,000 patients with heart disease identified from EHRs from seven of PCORnet’s Clinical Data Research Networks (CDRNs) and 30 different health systems. The Health eHeart Alliance Patient-Powered Research Network (PPRN) supports the Adaptors, a team of people with coronary heart disease who helped design the protocol, consent form, portal content, and study materials. Together the Adaptors and Health eHeart Alliance have developed patient-centered processes to facilitate engagement.

In ADAPTABLE, the role of the patient has shifted from that of a participant to partner. “Adaptors provide more than input, they are part of the research team and members of the executive and the steering committees. Two patients who are not Adaptors will sit on the data safety monitoring board. We have not seen this type of participation in traditional clinical research. We are learning a great deal from our patient partners and along the way we are transforming how clinical research is performed,” said Lisa G Berdan, Director, DCRI Global Cardiovascular Outcomes Trials.

Jacqueline Alikhaani, an Adaptor, offers this perspective, a view that is shared by her fellow Adaptors, “What we are doing in ADAPTABLE is landmark work. For the first time ever we are looking to improve patient-centered care with patients at the table, not just on the table. Research is necessary to determine if and how changes can best be made. This is why I volunteered to help design and implement the ADAPTABLE aspirin study.”

Heart disease is the leading cause of death for both men and women. About 610,000 people die of heart disease in the United States every year. It accounts for one in every four deaths and is a disease that places enormous burdens not only on patients and their families but on the nation and its healthcare system as a whole.

ADAPTABLE Steering Committee Co- Chairperson, Russell Rothman, MD, MPP, Principal Investigator of the Mid-South CDRN said, “Typically when a patient is diagnosed with heart disease they are prescribed baby or low-dose aspirin (81 mg) or regular strength (325mg). However, we actually don’t know the optimal dose of aspirin for balancing benefits in preventing a future heart attack or stroke against its risk of bleeding. Results of the ADAPTABLE study will provide doctors with a better understanding of which dose of aspirin is best for which patient so that we can improve healthcare delivery and patient outcomes.” Watch Dr. Rothman’s video to learn about the significance of ADAPTABLE and novel aspects of its design as a pragmatic clinical trial.

ADAPTABLE will help patients and health care providers determine the right dose to use in coronary artery disease. In addition, it will provide a new framework for how clinical trials can be delivered. For more information, visit www.theaspirinstudy.org or check out the patient portal at www.adaptablepatient.com.

About PCORnet

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research. More information is available at www.pcornet.org.

About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.

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